Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
- Registration Number
- NCT00354224
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.
Secondary
* Determine the tolerability and toxicity of this regimen in these patients.
* Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxaliplatin + Capecitabine capecitabine Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. Oxaliplatin + Capecitabine oxaliplatin Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.
- Primary Outcome Measures
Name Time Method Response Rate as Determined by RECIST. Every 6 weeks through study completion for up to about 18 weeks Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Every 6 weeks through study completion for up to about 18 weeks Number of Adverse Events From the start of study treatment through study completion for up to about 18 weeks
Trial Locations
- Locations (1)
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States